Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

University of Michigan

Status: Completed

Conditions: Caregivers

Treatments: Behavioral: Just-in-time adaptive intervention (JITAI); Behavioral: Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04570930

2R01NR013658 (U.S. NIH Grant/Contract)

HUM00181282

Details and patient eligibility

About

Care partners of persons with traumatic brain injury (TBI) are often faced with considerable physical and emotional stress resulting from their caregiver role. The researchers hypothesize that the care partners who receive the intervention will show improvements in caregiver strain and mental health.

Enrollment: 257 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be caring for an adult (age 18 or above) with a medically documented TBI that is ≥1-year post-injury and meets the TBI Model Systems (TBIMS) criteria for complicated mild, moderate or severe TBI and who sustained their TBI at age 16 or older
• Provide emotional, physical, and/or financial support/assistance to the individual with the TBI, indicating a response ≥1 to the following question: "On a scale of 0-10, where 0 is "no assistance" and 10 is "assistance with all activities", how much assistance does the person you care for require from you to complete activities of daily living due to problems resulting from his/her TBI? Activities could consist of personal hygiene, dressing and undressing, housework, taking medications, managing money, running errands, shopping for groceries or clothing, transportation, meal preparation and cleanup, remembering things, etc."
• Have access to necessary resources for participating in a technology-based intervention (smartphone/tablet and internet access) and be willing to use their personal equipment/internet for this study, including downloading the study app and the Fitbit® app on their mobile device
• Is able and willing to complete all study assessments for the duration of their study participation (approximately 375 days)

Exclusion criteria

• Is a professional, paid caregiver (e.g., home health aide)
• Anything that would preclude safe or meaningful participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

257 participants in 2 patient groups

Just-in-time adaptive intervention (JITAI)

Experimental group

Description:

Participants will wear the Fitbit®, provide daily reports of Health- Related Quality of Life (HRQOL) and receive personalized pushes over a six-month (180 day) period.

Treatment:

Behavioral: Just-in-time adaptive intervention (JITAI)

Control

Active Comparator group

Description:

Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).

Treatment:

Behavioral: Control